Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity

February 18, 2016 updated by: The HIV Netherlands Australia Thailand Research Collaboration

Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.

Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary objective:

To determine whether a switch to a SQV can cause improvements in renal function in patients with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction.

Secondary objective:

  1. To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48
  2. To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48
  3. To determine whether a switch to an SQV can cause improvements in renal pathophysiology in patients with chronic IDV associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48
  4. To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IDV containing regimen for more than 1 year and have creatinine more than 1.4 at least 6 months/abnormal renal imaging/abnormal urinary examinations
  • Viral load less than 50 copies

Exclusion Criteria:

  • Saquinavir intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Replace Indinavir with SQV in patients with indinavir toxicity
Drug: Saquinavir
SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Metabolic and cutaneous profile
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Roche Pharma AG
Ministry of Health, Thailand

Investigators

  • Principal Investigator: Kiat Ruxrungtham, MD, The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 20, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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